Leuzek

Package leaflet: Information for the patient

Leuzek, 100 mg, hard capsules
Imatinibum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Leuzek is and what it is used for
2. Important information before taking Leuzek
3. How to take Leuzek
4. Possible side effects
5. How to store Leuzek
6. Contents of the pack and other information

1. What Leuzek is and what it is used for

Leuzek is available as hard gelatin capsules containing the active substance imatinib. The medicine works by inhibiting the growth of abnormal cells in the diseases listed below, including certain types of cancer.
Leuzek is used in adults, children, and adolescents for the treatment of the following conditions:

• Chronic myeloid leukaemia (CML) in blast crisis. Leukaemia is a cancer of white blood cells. White blood cells help the body fight infections. Chronic myeloid leukaemia is a type of leukaemia in which certain abnormal white blood cells (called myeloid cells) begin to multiply uncontrollably. Blast crisis is the most advanced stage of this disease.
• Acute lymphoblastic leukaemia with the Philadelphia chromosome (Ph-positive ALL). Leukaemia is a cancer arising from white blood cells. Normally, white blood cells help the body fight infections. Acute lymphoblastic leukaemia is a type of leukaemia in which certain abnormal white blood cells (called lymphoblasts) begin to multiply uncontrollably. Leuzek inhibits the growth of these cells.

Leuzek is also used in children and adolescents for the treatment of:

• Newly diagnosed CML, when bone marrow transplantation is not considered as first-line treatment;
• Chronic phase CML after failure of interferon-alpha therapy, or in the accelerated phase. The accelerated phase is a transitional stage between the chronic phase and blast crisis. This phase is considered the first sign of developing treatment resistance.

Leuzek is also indicated for the treatment of adult patients with:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are blood disorders in which certain white blood cells begin to multiply uncontrollably. Leuzek inhibits the growth of these cells in certain subtypes of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood disorders in which certain blood cells (called eosinophils) begin to multiply uncontrollably. Leuzek inhibits the growth of these cells in certain subtypes of these diseases.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a tumour of the skin and subcutaneous tissues in which certain cells begin to multiply uncontrollably. Leuzek inhibits the growth of these cells.

In the remainder of this leaflet, abbreviated names of these diseases will be used.
If you have any questions about how Leuzek works or why this medicine has been prescribed, please consult your doctor.

2. Important information before using Leuzek

Leuzek must be prescribed only by a physician experienced in the use of drugs used in the treatment of haematological malignancies.
Strict adherence to the physician's instructions is essential, even if they differ from the general information contained in this leaflet.
When not to use Leuzek:

• if the patient is allergic to imatinib or to any of the other components of this medicine (listed in section 6).

If this applies to the patient, he/she should inform the doctor before taking Leuzek.
If the patient suspects he/she may be allergic but is not certain, he/she should consult a physician for advice.
Warnings and precautions
Before starting Leuzek, discuss the following with your doctor:

• if the patient has or has ever had liver, kidney, or heart disease.
• if the patient is taking levothyroxine following thyroid removal.
• if the patient has ever had, or may currently have, hepatitis B virus infection; this is because Leuzek may cause reactivation of hepatitis B virus infection, which in some cases may be fatal; patients will be closely monitored by the physician for signs of this infection before starting treatment.
• if the patient develops bruising, bleeding, fever, fatigue, or confusion while taking Leuzek, contact the physician immediately. These may be symptoms of a blood vessel disorder called thrombotic microangiopathy (TMA).

If any of the above points apply to the patient, he/she should inform the doctor before taking Leuzek.
While taking Leuzek, the patient may become more sensitive to sunlight. It is important to cover sun-exposed skin areas and to use sunscreen products with a high sun protection factor (SPF). These precautions should also be applied to children.
During treatment with Leuzek, the patient should inform the doctor immediately if rapid weight gain occurs. Leuzek may cause fluid retention (severe fluid retention).
During treatment with Leuzek, the physician will perform regular check-ups to monitor the effectiveness of treatment. Additionally, blood tests and regular body weight measurements will be performed during treatment.
Children and adolescents
Leuzek is also used in the treatment of children and adolescents with CML. There is a lack of data on the use of Leuzek in children with CML under 2 years of age. Experience with use in children with Ph-positive ALL is limited, and experience in children with MDS/MPD, DFSP, and HES/CEL is very limited.
In some children and adolescents taking Leuzek, growth may be slower than normal. The physician will monitor growth during regular visits.
Leuzek with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those the patient plans to use, even if available without a prescription (e.g. paracetamol), as well as herbal medicines (e.g. St John's wort). Some medicines may interact with Leuzek when used concomitantly. They may increase or decrease the effect of Leuzek, potentially leading to increased adverse effects or reducing the effectiveness of Leuzek. Leuzek may similarly affect the action of certain other medicines.
Inform the doctor if the patient is taking medicines to prevent blood clots.
Pregnancy, breastfeeding, and fertility

• If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
• Leuzek is not recommended during pregnancy unless absolutely necessary, as it may be harmful to the unborn child. The doctor will inform the patient about the potential risks associated with using Leuzek during pregnancy.
• Women who could become pregnant should use effective contraception during treatment with Leuzek and for 15 days after stopping treatment.
• Breastfeeding must be avoided during treatment with Leuzek and for 15 days after treatment ends, as it may harm the infant.
• Patients concerned about fertility during treatment with Leuzek should consult their doctor.

Driving and operating machinery
The patient may experience dizziness, drowsiness, or blurred vision while taking this medicine. In such cases, the patient should refrain from driving or operating machinery until feeling well again.
Leuzek contains a colouring agent called sunset yellow (E110)
The colouring agent in this medicine may cause allergic reactions.

3. How to take Leuzek

Your doctor has prescribed Leuzek because of your serious medical condition. Leuzek may help improve this condition.
This medicine should always be taken exactly as directed by your doctor or pharmacist. You must take the medicine for as long as your doctor recommends. If you have any doubts, consult your doctor or pharmacist.
You should continue taking Leuzek until your doctor decides to stop treatment. If you are unable to take the medicine as directed, or if you think you no longer need to take the medicine, you should contact your doctor immediately.

Recommended dose

Use in adults
Your doctor will determine exactly how many Leuzek capsules you should take.

• For treatment of blast crisis CML: The usual starting dose is 600 mg, depending on the patient's condition:
  • 600 mg taken as 6 capsules once daily.

In the treatment of blast crisis CML, your doctor may prescribe a higher or lower dose depending on your response to treatment. If the daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.

• For treatment of Ph-positive ALL: The starting dose is 600 mg, taken as 6 capsules once daily.
• For treatment of MDS/MPD: The starting dose is 400 mg, taken as 4 capsules once daily.
• For treatment of HES/CEL: The starting dose is 100 mg, taken as one capsule once daily. Your doctor may decide to increase the dose to 400 mg (4 capsules) once daily, depending on your response to treatment.
• For treatment of DFSP: The daily dose is 800 mg (8 capsules), taken as 4 capsules in the morning and 4 capsules in the evening.

Use in children and adolescents
Your doctor will determine how many Leuzek capsules should be given to the child. The amount of Leuzek depends on the child's condition, body weight, and height. The total daily dose for children and adolescents must not exceed 800 mg in the treatment of CML and 600 mg in the treatment of Ph-positive ALL. The dose may be given once daily or divided into two doses (half in the morning and half in the evening).

When and how to take Leuzek

• Leuzek should be taken with food, which may help protect you from stomach problems while taking Leuzek.

• Swallow the capsules whole with a large glass of water. Do not open or crush the capsules unless you have difficulty swallowing (e.g., in children).

• If you cannot swallow the capsules, you may dissolve the contents of the capsule in approximately 50 mL (for a 100 mg capsule) of non-carbonated water or apple juice (mix thoroughly with a spoon until the capsule contents are completely dissolved, then drink the entire contents of the glass immediately).

• Women who are pregnant or could become pregnant and who open capsules should handle the contents with care: avoid contact of the powder with skin and eyes, and do not inhale it. Hands should be washed immediately after opening the capsules.

How long to take Leuzek
Leuzek should be taken every day for as long as your doctor recommends.

Taking more Leuzek than you should
If you accidentally take too many capsules, you must contact your doctor immediately. You may require medical attention. Take the medicine packaging with you.

Missed dose of Leuzek

• If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose.
• Then continue with your regular dosing schedule.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
They are usually mild to moderate.
Some adverse reactions may be serious. You should immediately inform your doctor
if any of the following symptoms occur:
Very common (occurring in more than 1 in 10 patients) or common (occurring in less than 1 in 10 patients)
adverse reactions:

• Rapid weight gain. Leuzek may cause fluid retention (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat, and mouth ulcers. Leuzek may reduce the number of white blood cells in the blood, making the patient more susceptible to infections.
• Unexpected bleeding or bruising (despite no injury).

Uncommon (occurring in less than 1 in 100 patients) or rare (occurring in less than 1 in 1000 patients)
adverse reactions:

• Chest pain, irregular heartbeat (symptoms of heart problems).
• Cough, difficulty breathing, or pain during breathing (symptoms of lung problems).
• Feeling faint, dizziness, or fainting (symptoms of low blood pressure).
• Nausea with loss of appetite, dark urine, yellowing of the skin or eyes (symptoms of liver disease).
• Rash, redness of the skin with blisters on the lips, around the eyes, on the skin, or in the mouth, skin peeling, fever, raised red or purple spots on the skin, itching, burning sensation, pustular rash (symptoms of skin problems).
• Severe abdominal pain, presence of blood in vomit, stool, or urine, black stools (symptoms of stomach and intestinal disorders).
• Significantly reduced urine output, feeling thirsty (symptoms of kidney problems).
• Nausea with diarrhea and vomiting, abdominal pain, or fever (symptoms of intestinal problems).
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (symptoms of nervous system problems such as bleeding or swelling within the skull/brain).
• Pale skin, feeling tired and short of breath, dark-colored urine (symptoms of red blood cell deficiency).
• Eye pain or blurred vision, bleeding in the eye.
• Hip pain or difficulty walking.
• Numbness or cold sensation in fingers and toes (symptoms of Raynaud's syndrome).
• Sudden swelling and redness of the skin (symptoms of skin infection called connective tissue inflammation).
• Hearing difficulties.
• Muscle weakness and muscle cramps with irregular heartbeat (symptoms of changes in potassium levels in the patient's blood).
• Bruising.
• Stomach pain with nausea.
• Muscle cramps associated with fever, red-brown urine, muscle pain or weakness (symptoms of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, sudden vaginal bleeding, dizziness or fainting caused by low blood pressure (symptoms of ovarian or uterine problems).
• Nausea, shortness of breath, irregular pulse, cloudy urine, fatigue and (or) joint complaints accompanied by abnormal laboratory test results (e.g. high levels of potassium, uric acid and calcium, and low levels of phosphorus in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).
• Painful red nodules on the skin, skin pain, redness of the skin (inflammation of subcutaneous fat tissue).

Frequency unknown (cannot be estimated from available data):

• Co-occurrence of widespread, severe rash, nausea, fever, high number of certain white blood cells, or yellowing of the skin or eyes (jaundice symptoms) with shortness of breath, chest pain/discomfort, markedly reduced urine output, and thirst, etc. (symptoms of an allergic reaction related to treatment).
• Chronic kidney failure.
• Recurrence (reactivation) of hepatitis B virus infection (liver infection) in patients who have previously had this disease.

If any of the above adverse reactions occur, you should immediately inform your doctor.
Other adverse reactions may include:
Very common adverse reactions (occurring in more than 1 in 10 patients):

• Headache or fatigue.
• Nausea, vomiting, diarrhea, or indigestion.
• Rash.
• Muscle cramps, muscle or bone pain, occurring during or after discontinuation of Leuzek.
• Swelling, e.g., swelling of ankles or around the eyes.
• Weight gain. If any of these symptoms occur severely, you should inform your doctor.

Common adverse reactions (occurring in less than 1 in 10 patients):

• Loss of appetite, weight loss, or taste disturbances.
• Dizziness or weakness.
• Sleep disturbances (insomnia).
• Eye discharge with itching, redness, and swelling (conjunctivitis), excessive tearing, or blurred vision.
• Nosebleeds.
• Pain or swelling in the abdomen, bloating with passing wind, heartburn, or constipation.
• Itching.
• Excessive hair loss or thinning.
• Numbness of hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin, or dry eyes.
• Decreased or increased skin sensitivity.
• Hot flushes, chills, or night sweats. If any of these symptoms occur severely, you should inform your doctor.

Unknown frequency (frequency cannot be estimated from available data):

• Redness and (or) swelling of the palms and soles, which may be accompanied by tingling and burning pain.
• Skin changes with pain and/or blister formation.
• Slowed growth in children and adolescents.

If any of the above symptoms worsen, you should inform your doctor.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of using this medicine.

5. How to store Leuzek

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Do not use packs that are damaged or show signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Leuzek contains

• The active substance is imatinib. Each Leuzek capsule contains 100 mg of imatinib in the form of imatinib mesylate.
• Other components: capsule shell ingredients: gelatin, titanium dioxide; printing ink ingredients: shellac, concentrated ammonium hydroxide, propylene glycol, orange yellow.

What Leuzek looks like and contents of the pack
100 mg: hard gelatin capsules, white or almost white, printed with "100".
Pack size: 60 or 120 capsules.
Marketing Authorisation Holder
Nobilus Ent Tomasz Koźluk
ul. Swarzewska 45
01-821 Warsaw
Poland
Manufacturer
NOBILUS ENT
ul. Swarzewska 45
01-821 Warsaw
Poland